DRAXIMAGE MAA - kit for the preparation of technetium tc 99m albumin aggregated injection, powder, for solution
Jubilant DraxImage Inc
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DRAXIMAGE® MAA safely and effectively. See full prescribing information for DRAXIMAGE MAA.
DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection, for intravenous or intraperitoneal use Initial U.S. Approval: 1987 INDICATIONS AND USAGEDRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is a radioactive diagnostic agent indicated for: DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSKit for the preparation of Technetium Tc 99m Albumin Aggregated Injection: 2.5 mg of albumin aggregated as a lyophilized powder in a multiple-dose reaction vial. Upon radiolabeling, it provides a suspension of Technetium Tc 99m Albumin Aggregated Injection. Each vial contains 3,000,000 to 8,000,000 particles. (3) CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction. (6) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONSLactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 24 hours after Technetium Tc 99m Albumin Aggregated Injection administration. (8.2) See 17 for PATIENT COUNSELING INFORMATION. Revised: 2/2024 |
DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for:
After radiolabeling of DRAXIMAGE MAA, the vial contains Technetium Tc 99m Albumin Aggregated Injection. Handle Technetium Tc 99m Albumin Aggregated Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.4)]. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Albumin Aggregated Injection.
Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Albumin Aggregated Injection and to continue to drink and void frequently following administration to reduce radiation exposure [see Warnings and Precautions (5.4)].
Adult Patients
The recommended activity for lung perfusion scintigraphy in adult patients is 37 MBq to 148 MBq (1 mCi to 4 mCi) by intravenous injection.
The number of particles per single injection should be 200,000 to 700,000 with the recommended number being approximately 350,000. Depending on the activity added and volume of the final radiolabeled product, the volume of the dose may vary from 0.2 mL to 1.9 mL.
The number of particles available per dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the technetium-99m that has occurred. The number of particles in any dose and volume to be administered may be calculated as follows:
Va = D and P = Va x N
C x Fr VTc
Where:
Va = Volume to be administered in mL
D = Desired activity to be administered in MBq (mCi)
C = Concentration at calibration time of Sodium Pertechnetate Tc 99m Injection to be added to the reaction vial in MBq/mL (mCi/mL)
Fr = Fraction of technetium-99m remaining after the time of calibration from Table 7[see Description (11.3)]
P = Number of particles in dose to be administered
Va = Volume to be administered in mL
VTc = Volume of Sodium Pertechnetate Tc 99m Injection added to reaction vial in mL
N = Number of particles per vial. The number of particles per vial for each lot is shipped with the product.
Pediatric Patients Aged 4 Weeks and Older
The recommended activity for lung perfusion scintigraphy in pediatric patients aged 4 weeks and older by intravenous injection is based on body weight and ranges from 0.925 MBq/kg to 1.85 MBq/kg (0.025 mCi/kg to 0.05 mCi/kg). The minimum recommended activity for lung perfusion scintigraphy in this age group is 7.4 MBq (0.2 mCi).
The number of particles will vary with age and body weight of the pediatric patient. Particle numbers administered in four different age and weight categories are provided in Table 1.
Table 1. Particle Numbers Administered in Four Different Age and Weight Categories of Pediatric Patients Receiving Maximum Recommended Activity of Technetium Tc 99m Albumin Aggregated Injection for Lung Perfusion Scintigraphy
Age
| 15 years | 10 years | 5 years | 1 year |
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Weight (kg)
| 55 | 33.5 | 20.3 | 12.1 |
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Maximum recommended activity
| MBq
| mCi
| MBq
| mCi
| MBq
| mCi
| MBq
| mCi
|
|
103.6 | 2.8 | 62.9 | 1.7 | 37 | 1 | 22.2 | 0.6 |
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Range of particles administered | 200,000 to 700,000 | 200,000 to 300,000 | 200,000 to 300,000 | 50,000 to 150,000 |
Pediatric Patients Aged Less Than 4 Weeks (Neonates)
The recommended activity for lung perfusion scintigraphy in neonates by intravenous injection is 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi). The number of particles in neonates for lung perfusion scintigraphy ranges from 10,000 to 50,000. Use the lowest possible number of particles for neonates.
The recommended activity for peritoneovenous shunt scintigraphy in adult patients is 37 MBq to 111 MBq (1 mCi to 3 mCi) by intraperitoneal injection. The number of particles per single injection should be 200,000 to 700,000 with the recommended number being approximately 350,000. Depending on the activity added and volume of the final radiolabeled product, the volume of the dose may vary from 0.2 mL to 1.9 mL. For calculation of the number of particles to be administered, see Recommended Dosage for Lung Perfusion Scintigraphy in Adult Patients [see Dosage and Administration (2.3)]. Assure uniform mixing with peritoneal fluid.
Alternatively, administer the drug by percutaneous transtubal injection. The recommended activity for percutaneous transtubal (efferent limb) administration in adult patients is 12 MBq to 37 MBq (0.3 mCi to 1 mCi) in a volume not to exceed 0.5 mL.
Procedural Precautions
Procedure for the Preparation of Technetium Tc 99m Albumin Aggregated Injection
Particles per vial
| Maximum Activity of Sodium Pertechnetate Tc 99m Injection to be added per vial
|
3 million to 4 million | 3.7 GBq (100 mCi) |
5 million | 4.44 GBq (120 mCi) |
6 million to 8 million | 6.85 GBq (185 mCi) |
Storage and Handling of Technetium Tc 99m Albumin Aggregated Injection
Intravenous Administration
Estimated radiation absorbed doses from intravenous administration are shown in Table 3.
Absorbed Dose per Activity Administered
(microGy/MBq) |
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Organs
| Adults
| 15 years
| 10 years
| 5 years
| 1 year
| Neonates
|
Total body | 4.05 | 3.96 | 7.63 | 8.38 | 13.5 | 32.4 |
Lungs | 59.5 | 74.3 | 138 | 157 | 297 | 1027 |
Liver | 4.86 | 11.6 | 28.6 | 16.8 | 27 | 75.7 |
Spleen | 4.59 | *-- | -- | -- | -- | -- |
Kidneys | 2.97 | -- | -- | -- | -- | -- |
Bladder Wall 2 hour void 4.8 hour void No voiding intervals | 8.11 14.9 -- | -- -- 39.6 | -- 62 -- | -- 83.8 -- | 67.6 -- -- | 114 -- -- |
Testes 2 hour void 4.8 hour void No voiding intervals | 1.62 1.76 -- | -- -- 3.47 | -- -- 3.18 | -- -- 5.14 | -- -- 5.86 | -- -- 16.8 |
Ovaries 2 hour void 4.8 hour void No voiding intervals | 2.03 2.3 -- | -- -- 3.96 | -- -- 7 | -- -- 5.14 | -- -- 9.01 | -- -- 20.5 |
*--: Not available
Intraperitoneal Administration
Estimated radiation absorbed doses from intraperitoneal administration are shown in Table 4.
Absorbed Dose per Activity Administered
(microGy/MBq) |
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Organs |
Shunt Patency (Open) |
Shunt Patency (Closed) |
Lung |
62.2 |
15.1 |
Ovaries or Testes |
1.62 to 2.7 |
15.1 |
Organ in the Peritoneal Cavity |
*-- |
15.1 |
Total Body |
3.24 |
5.14 |
*--: Not available
Kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection: 2.5 mg of albumin aggregated as a non-radioactive white lyophilized powder in a multiple-dose reaction vial for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare a suspension of Technetium Tc 99m Albumin Aggregated Injection. Each vial contains 3,000,000 to 8,000,000 particles.
DRAXIMAGE MAA is contraindicated in patients with:
Deaths have been reported in patients with severe pulmonary hypertension after the administration of technetium Tc 99m albumin aggregated products [see Adverse Reactions (6)].Assess patients for history or signs of pulmonary hypertension. DRAXIMAGE MAA is contraindicated in patients with severe pulmonary hypertension [see Contraindications (4)].Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions.
Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with products containing albumin human, including DRAXIMAGE MAA [see Adverse Reactions (6)]. Obtain a history of allergy or hypersensitivity reactions. DRAXIMAGE MAA is contraindicated in patients with a history of hypersensitivity to albumin human [see Contraindications (4)] . Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Monitor all patients for signs or symptoms of hypersensitivity reactions.
In patients with right-to-left heart shunts, risk for temporary mechanical impediment to blood flow may exist due to the rapid entry of aggregated albumin into the systemic circulation. Administer the lowest possible number of particles of Technetium Tc 99m Albumin Aggregated Injection in these patients.
Technetium Tc 99m albumin aggregated contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.2)].
The following clinically significant adverse reactions are described elsewhere in the labeling:
The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including DRAXIMAGE MAA were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular Disorders: Deaths in patients with severe pulmonary hypertension
Immune System Disorders: Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain and syncope, urticaria, reddening of the face, sweating, and nausea
Skin and Subcutaneous Tissue Disorders: Injection site reactions
Risk Summary
Available data with Technetium Tc 99m Albumin Aggregated Injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted Radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. The radiation exposure to the fetus from technetium Tc 99m albumin aggregated is expected to be low (less than 0.5 mGy) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
Data
Human Data
No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
Risk Summary
Technetium-99m is present in breast milk. There are no data on the effects of technetium Tc 99m albumin aggregated on the breastfed infant or the effects on milk production. DRAXIMAGE MAA is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower. Based on clinical guidelines, exposure of technetium Tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of Technetium Tc 99m Albumin Aggregated Injection.
The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for DRAXIMAGE MAA, any potential adverse effects on the breastfed child from technetium Tc 99m albumin aggregated or from the underlying maternal condition.
DRAXIMAGE MAA, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). The safety profile of Technetium Tc 99m Albumin Aggregated Injection in pediatric patients is similar to adults.
The safety and efficacy of DRAXIMAGE MAA have not been established for peritoneovenous shunt scintigraphy in pediatric patients.
No formal studies of DRAXIMAGE MAA in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. In general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
DRAXIMAGE MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by denaturation of albumin human in a heating and aggregation process. Each vial contains 3,000,000 to 8,000,000 particles. By light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers.
DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder supplied in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use.
Each reaction vial contains 2.5 mg of albumin aggregated, albumin human (5 mg), stannous chloride (0.06 mg minimum; 0.11 mg maximum stannous and stannic chloride) and sodium chloride (1.2 mg). Sodium hydroxide or hydrochloric acid has been added for pH adjustment. The pH is 5.2 to 6. It contains no preservative.
Technetium-99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 5.
Radiation
| Mean % per Disintegration
| Mean Energy (keV)
|
Gamma
| 89.07
| 140.5 |
The specific gamma ray constant for technetium-99m is 0.78 R/mCi-hr at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 6. For example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1,000.
Shield Thickness
(Pb) cm | Coefficient of
Attenuation |
0.017 | 0.5 |
0.08 |
10-1 |
0.16 | 10-2
|
0.25 | 10-3
|
0.33 | 10-4
|
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 7.
Hours
| Fraction
Remaining | Hours
| Fraction
Remaining |
0* | 1.000 | 5 | 0.562 |
1 | 0.891 | 6 | 0.501 |
2 | 0.794 | 8 | 0.398 |
3 | 0.708 | 10 | 0.316 |
4 | 0.631 | 12 | 0.251 |
*Calibration time
Following intravenous injection, more than 80% of the technetium Tc 99m albumin aggregated particles is trapped in the pulmonary alveolar capillary bed within 5 minutes.
Following intraperitoneal injection, technetium Tc 99m albumin aggregated mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent.
The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of technetium Tc 99m albumin aggregated have not been fully characterized.
Distribution
Organ selectivity is a direct result of particle size. Albumin aggregated from 1 micrometer to 10 micrometers size are taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates become lodged in the lung by trapping in the pulmonary alveolar capillary bed. Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Distribution of particles in the lungs is a function of regional pulmonary blood flow.
The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be temporary. Erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. The fragments are then accumulated by the reticuloendothelial system.
Elimination
Elimination of the technetium Tc 99m albumin aggregated particles from the lungs occurs with a half-life of about 2 to 3 hours. Cumulative urinary excretion studies show an average of 20% elimination of the injected technetium Tc 99m albumin aggregated dose in 24 hours post-administration.
How Supplied
DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection contains 2.5 mg of albumin aggregated as a white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection. It contains no preservative.
DRAXIMAGE MAA is supplied in a carton (NDC 65174-270-30) containing 30 multiple-dose reaction vials (NDC 65174-270-01) and 30 radioassay information labels.
Storage and Handling
Before radiolabeling, store the supplied reaction vials at 2 ºC to 25ºC (36 ºF to 77 ºF).
After radiolabeling with Sodium Pertechnetate Tc 99m Injection, store Technetium Tc 99m Albumin Aggregated Injection in a lead vial shield with cap in place, refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) when not in use. Use within 12 hours after radiolabeling [see Dosage and Administration (2.5)].
Dispose unused Technetium Tc 99m Albumin Aggregated Injection in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.
This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
Adequate Hydration
Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their imaging and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Aggregated Albumin Injection, in order to reduce radiation exposure[see Dosage and Administration (2.2)].
Pregnancy
Advise pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionucleotide procedure [see Use in Specific Populations (8.1)].
Lactation
Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for at least 24hours after Technetium Tc 99m Albumin Aggregated Injection administration to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2)].
Manufactured by:
Jubilant DraxImage Inc.
16 751 TransCanada Highway
Kirkland, Quebec H9H 4J4 Canada
1-888-633-5343
US License Number: 2186
Rev. Art: 4.0
412575
DRAXIMAGE® is a registered trademark of Jubilant DraxImage Inc.
DRAXIMAGE MAA
kit for the preparation of technetium tc 99m albumin aggregated injection, powder, for solution |
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Labeler - Jubilant DraxImage Inc (243604761) |
Registrant - Jubilant DraxImage Inc (243604761) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Jubilant HollisterStier General Partnership | 246762764 | MANUFACTURE(65174-270) |